DC-1 CARDIAC IMAGING MODULE
FDA 510(k) clearance K811556 · decided 1981-07-10
Clearance details
- K-number
- K811556
- Device name
- DC-1 CARDIAC IMAGING MODULE
- Applicant
- Diasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-02
- Decision date
- 1981-07-10
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- DXK
- Device class
- 2
- Regulation number
- 870.2330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diasonics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DIASONICS NMR IMAGING SYSTEM (P830053/S030) | Diasonics, Inc. | 1988-07-27 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S029) | Diasonics, Inc. | 1988-07-07 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S028) | Diasonics, Inc. | 1988-03-03 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S026) | Diasonics, Inc. | 1987-07-13 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S027) | Diasonics, Inc. | 1987-06-22 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S022) | Diasonics, Inc. | 1987-03-30 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S025) | Diasonics, Inc. | 1987-03-20 |
| DIASONICS NMR IMAGING SYSTEM (P830053/S024) | Diasonics, Inc. | 1987-03-17 |